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  1. 1. Ensayo clínico
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Kerndatensatz Herzinsuffizienz DZHI (Core data set heart failure CHFC) - Untersuchung Herzinsuffizienz (Examination heart failure)

- 24/3/20 - 1 modulo, 5 itemgroups, 90 elementi, 2 lingue
Itemgroups: Logistics , Physical examination, ECG, 6MWT, Echocardiography
Core data set on heart failure, developed by the Comprehensive Heart Failure Center (CHFC). The CHFC researches and treats the complex disease heart failure and its comorbidities in a comprehensive approach. This form contains information about the examination of an heart failure Kerndatensatz zu Herzinsuffizienz, entwickelt vom Deutschen Zentrum für Herzinsuffizienz (DZHI). Das DZHI erforscht und therapiert in einem ganzheitlichen Ansatz die Systemerkrankung Herzinsuffizienz samt ihrer Begleit- und Folgeerkrankungen. Dieses Formular enthält Informationen über die Untersuchung einer Herzinsuffizienz.

26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 20/9/21 - 13 moduli, 3 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Global Disease Course, Red Cell Transfusion, Platelet Cell Transfusion
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Physical Examination/Follow up

3 itemgroups 14 elementi

Administrative/Demographic Details

1 ItemGroup 11 elementi

Medical History

3 itemgroups 9 elementi

Lab: Cytology/Cytogenetics/Cytochemistry

1 ItemGroup 29 elementi

Lab: Immunophenotyping

1 ItemGroup 17 elementi

Lab: Molecular Genetics

1 ItemGroup 27 elementi

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Baseline Visit

- 14/11/17 - 1 modulo, 10 itemgroups, 71 elementi, 2 lingue
Itemgroups: Physical Examination / Medical History taking, Signs and Symptoms of heart failure, Cardiovascular Diseases, Comorbidities, Current medication, Cardiovascular interventions, Implantation of a cardiac device, Hematology, ECG, Baseline visit
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Baseline Visit (BV-Form)

EHR4CR Complete Data Inventory - EHR4CR Data Inventory

- 10/2/17 - 1 modulo, 13 itemgroups, 122 elementi, 1 linguaggio
Itemgroups: Demographics, Diagnoses and Procedures, Vital Signs, Laboratory, Generic Laboratory Data, Medication, Adverse Events, Medical History, Clinical Findings, ECG, Patient Reported Outcome, Substance Use, Study Participation Status
Compilation of Feasibility, Patient Identification & Recruitment and Clinical Trial Execution data inventories. https://www.ncbi.nlm.nih.gov/pubmed/24410735 https://www.ncbi.nlm.nih.gov/pubmed/25991199 https://www.ncbi.nlm.nih.gov/pubmed/27875988

CDASH Vital Signs

- 20/6/18 - 1 modulo, 2 itemgroups, 14 elementi, 2 lingue
Itemgroups: General information, Vital Sign
modified from http://www.cdisc.org

Physical examination findings (EHR Archetype) - openEHR-EHR-OBSERVATION.exam.v1

- 10/7/17 - 1 modulo, 1 ItemGroup, 8 elementi, 7 lingue
ItemGroup: openEHR-EHR-OBSERVATION.exam.v1.xml
Derived from www.openehr.org . Use to record details about findings on physical examination of the subject of care. This may include a narrative description of the findings, a framework in which to nest detailed CLUSTER examination archetypes, and a clinical interpretation of the findings. Examples of detailed CLUSTER examination archetypes include those that describe inspection, palpation, auscultation, percussion and movement of body systems or anatomical structures, such as CLUSTER.exam_pupils. Narrative descriptions of clinical findings from existing clinical systems may be captured using the 'Description' data element. Clinicians may sometimes want to record a summative phrase such as 'chronic otitis media' as an Interpretation of the physical examination. In the context of the physical examination archetype this should only be understood as 'physical signs are consistent with chronic otitis media'. While the summative phrase may appear to represent a diagnosis, safe and consistent querying requires a diagnosis to be recorded using the EVALUATION.problem_diagnosis archetype, even if the phrases are identical.

Study SHIP-START_SHIP2_DER - s2.cvifot1

- 26/10/24 - 21 moduli, 1 ItemGroup, 10 elementi, 2 lingue
ItemGroup: s2.cvifot1
SHIP Study https://doi.org/10.1093/ije/dyac034

s2.cvibes

1 ItemGroup 38 elementi

s2.melder

1 ItemGroup 42 elementi

s2.meltyp

1 ItemGroup 10 elementi

s2.duppid

1 ItemGroup 9 elementi

s2.intpid

1 ItemGroup 11 elementi

s2.cviklk

1 ItemGroup 11 elementi

German Center for Diabetes Research (DZD) - Core Data Set - Base set

- 15/7/24 - 2 moduli, 8 itemgroups, 147 elementi, 2 lingue
Itemgroups: IG.1, IG.2, IG.3, IG.4, IG.5, IG.6, IG.7, Fragebogen
The German Center for Diabetes Research (DZD) has created a core data set for research on diabetes. It is published with permission by the DZD. The complete metadata and SOP are registered at DOI 10.5281/zenodo.7360000 For more information on the work of the DZD see: www.dzd-ev.de/en or contact: studien@dzd-ev.de German Center for Diabetes Research (DZD) Head Office at Helmholtz Zentrum München Ingolstädter Landstr. 1 85764 Neuherberg, Germany The German and English version of the Baecke Questionnaire in this core data set is based on the original paper by Baecke et al (https://doi.org/10.1093/ajcn/36.5.936), redistributed by ten Velde et al. (https://doi.org/10.1371/journal.pone.0256448), and the German translation and modification by Wagner & Singer (2003). The questionnaire was selectively modified by the German Diabetes Center (DDZ). Changes in this version 4 (15.07.2024) compared to version 3 (26.02.2024) include the addition of the parameters defined in the core data set of the German Centers for Health Research (DZG) (ID of MDM entry: 45851), the addition of laterality-specific blindness and an update of the terminology coding. The coding of the DZG parameters is currently under revision and not included in this current version. The coding of those DZG parameters that were already included in the DZD CDS will be provisionally retained.

Optional Set

3 itemgroups 46 elementi

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Week 13 (Visit 8)

- 1/4/22 - 1 modulo, 6 itemgroups, 37 elementi, 1 linguaggio
Itemgroups: Date of physical examination, B- Symptoms, Physical Examination, Organ/ System, Hematology, Chemistry
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Premature Study Withdrawal Visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19/2/22 - 1 modulo, 10 itemgroups, 33 elementi, 1 linguaggio
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Premature Study Withdrawal Visit

Visit 12 (Week 96) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19/2/22 - 1 modulo, 10 itemgroups, 41 elementi, 1 linguaggio
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 12 (Week 96)

Baseline Visit (Day 1): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19/2/22 - 1 modulo, 3 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Subject Identification, Vital Signs, Physical examination
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Baseline Visit (Day 1)

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